Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

FDA Cites Akorn for Contamination Protections, Aseptic Processing

The FDA hit Akorn with a lengthy Form 483 with 13 observations for failing to properly safeguard against microbiological contamination and to monitor conditions in aseptic processing areas following April/May inspections of its Decatur, Illinois, facility.

The agency faulted the facility’s control procedures for lacking a baseline for what constitutes “foreign matter” during the visual inspection process for finished sterile injectable drug products.

Inspectors found the facility also failed to follow its SOPs on cleaning and sanitizing of manufacturing areas on several occasions after observing operators in aseptic areas placing fallen vials back onto the line.